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Completed

NCT Number: NCT01694134

Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

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Key information

Conditions

Low Back Pain Back Pain Lumbago Modic I Discopathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital University of Montpellier

Montpellier, 34000, France

About this study

This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years
  • Signed Informed consent
  • Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)

Exclusion criteria

  • Past history of lumbar surgery
  • Patient under anticoagulant or antisludge treatment, or with coagulation troubles
  • Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
  • Patient with unstabilized high blood pressure (> 160/95 mmHg)
  • Patient with evolving infection
  • Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
  • Porphyria, hypersensitivity to local anaesthetic
  • Patient with sphincter troubles showing a cauda equine syndrome
  • Untreated psychotic state
  • Pregnant women or of childbearing age without effective contraception means
  • Impossible 6 months follow-up
  • Participation to another trial
  • Vulnerable persons protected by the law
  • Persons under guardianship
  • Persons unable to express their consent

Treatment and study plan

Hydrocortancyl.

Drug

Patients will receive an intradiscal injection of hydrocortancyl.

Lidocaine

Drug

Primary outcomes

  1. Pain assessment: VAS

    Time frame: 1 month

    The pain will be assessed by the visual analog scale (VAS).

Secondary outcomes

  1. Pain assessment: VAS

    Time frame: 1 week, 2 weeks, 3 weeks, 3 months, 6 months

    The pain will be assessed by the visual analog scale (VAS).

  2. Quality of life assessment: SF-36

    Time frame: 1 month, 3 months, 6 months

    Quality of life will be assessed by the self-questionnaire SF-36.

  3. Consumption of analgesics and NSAIDs assessment

    Time frame: 1 month, 3 months,6 months

  4. Specific low back pain parameters assessment

    Time frame: 1 month, 3 months,6 months

    Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .

  5. Specific low back pain parameters assessment

    Time frame: 1 month, 3 months,6 months

    Low back pain parameters will be assessed by the Oswestry scale. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

  6. Employment status

    Time frame: 1 month, 3 months,6 months

    Employment or non-employment status will be noted

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: MODISC

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2012
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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